Thank you for clarifying that point. To be clear, my narrative wasn’t suggesting that the Eden system is being folded into the current MHRA approval. The reference to 2026 is consistent with GV’s comments and the company’s February 2024 press release, which explained that Advent would complete GMP validation of the Eden automated manufacturing system and then submit the data to regulators for approval of its use in production. My reply was only intended to clarify the expected timing of the next MHRA GMP audit and outline the possible scenarios. Based on the standard MHRA audit cycle and your discussion with GV, it appears that by around 2026 the Eden device and its associated Grade C suites would likely complete qualification and be formally added to the DCVax licence through a standard Type II variation.
FWIW The narrative itself was only exploring how the UCLA viscoelastic APC paper scientifically validates Eden’s design and regulatory readiness, it was not a commentary on the current approval process.
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